Bronchiale Thermoplastie bei Asthmapatienten mit schwerer Obstruktion: Benefit und Komplikationsrisiko

2020 ◽  
Vol 8 (1) ◽  
pp. 24-25
Author(s):  
Lars Hagmeyer
Keyword(s):  
Adverse Event ◽  
Treatment Efficacy ◽  
Randomized Clinical Trials ◽  
Medication Use ◽  
Adverse Outcomes ◽  
Similar Degree ◽  
Asthma Control Questionnaire ◽  
Safety And Efficacy ◽  
Reliever Medication ◽  
Oral Steroids

Background: Randomized clinical trials of bronchial thermoplasty (BT) were conducted in patients with a baseline FEV1 greater than 50%. There is a paucity of data regarding BT in patients with more severe obstruction, and consequently these patients are often excluded from receiving BT. The purpose of this study was to compare safety and efficacy outcomes in a large cohort of patients with an FEV1 less than 50% with those of a cohort of less obstructed patients. Methods: Consecutive patients with severe asthma were drawn from the Australian BT Registry. Patients were grouped into (1) those with a baseline prebronchodilator FEV1 % predicted <50% (n = 32) or (2) those with an FEV1 ≥50% (n = 36). Adverse outcomes were defined as (1) remaining in hospital longer than the planned 24-hour admission posttreatment or (2) being readmitted to hospital for any cause within 30 days of a treatment. Efficacy outcomes were evaluated 6 months after BT. Results: More severely obstructed patients were no more likely to have experienced any adverse event. Significant improvements in Asthma Control Questionnaire score, exacerbation frequency, reliever medication use, and requirement for daily oral steroids were observed in both groups, and were of a similar degree. Conclusions: This study demonstrates that BT can confidently be offered to patients with asthma with an FEV1 that is 30% to 50% of predicted without risk of more frequent or more severe adverse events, and with the expectation of the same degree of response as patients with better lung function.

scholarly journals Use of potentially inappropriate medications among ambulatory home-dwelling elderly patients with dementia: A review of the literature

2017 ◽  
Vol 150 (3) ◽  
pp. 169-183 ◽  
Author(s):  
Tejal Patel ◽  
Karen Slonim ◽  
Linda Lee
Keyword(s):  
Older Adults ◽  
Cognitive Impairment ◽  
Adverse Events ◽  
Inappropriate Medication ◽  
Medication Use ◽  
Adverse Outcomes ◽  
Potentially Inappropriate Medication ◽  
Potentially Inappropriate Medications ◽  
Inappropriate Medication Use ◽  
Inappropriate Medications

Background: Older adults with dementia are at high risk for drug-related adverse outcomes. While much is known about potentially inappropriate medication use in older adults, its prevalence and characteristics among those with dementia are not as well elucidated. We conducted a literature review to examine the prevalence of potentially inappropriate medication use among home-dwelling older adults with dementia. Our secondary aim was to determine the most frequently implicated medications and factors associated with potentially inappropriate medication use. Methods: MEDLINE, EMBASE, CINAHL, and International Pharmaceutical Abstracts were searched between 1946 and 2014 for articles that referenced potentially inappropriate medication use and types of dementia. One reviewer screened all titles and abstracts from the initial search and full-text articles after the initial screen for eligibility, then 2 reviewers independently abstracted data from included studies. Results: Searches yielded 81 articles, of which 7 met inclusion criteria. Prevalence of potentially inappropriate medication use varied from 15% to 46.8%. No single drug or drug class was reported consistently across all studies as the most frequent potentially inappropriate medication, but anticholinergics and benzodiazepines, drugs that affect cognition, were among the most common medications or pharmacological classes listed. Discussion: Older adults with dementia may be particularly vulnerable to potentially inappropriate medications because of cognitive impairment from their condition and the greater likelihood of experiencing adverse events from medications. Given this population’s greater susceptibility to adverse events, more intense medication and patient monitoring may be warranted, especially among those taking anticholinergics and benzodiazepines, as these drugs can contribute to cognitive impairment.

Abstract P476: Safety and Efficacy of Balloon Mounted Drug-Eluting Stent in the Treatment of Symptomatic Intracranial Atherosclerotic Disease Multicenter International Experience

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Mahmoud Mohammaden ◽  
Raul G Nogueira ◽  
WONDWOSSEN TEKLE ◽  
farhan siddiq ◽  
Diogo C Haussen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Endovascular Treatment ◽  
Medical Management ◽  
Randomized Clinical Trials ◽  
Atherosclerotic Disease ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Intracranial Atherosclerotic Disease ◽  
Drug Eluting

Introduction: Intracranial atherosclerotic disease (ICAD) is a common cause of refractory stroke. Randomized clinical trials failed to prove the safety and efficacy of the endovascular treatment options of symptomatic ICAD (sICAD). However, there are many concerns regarding inclusion criteria in these trials which made them less effective than standard medical management. Herein, we aim to study the safety and efficacy of drug-eluting balloon mounted stents (DES) in the treatment of sICAD. Methods: A retrospective review of endovascular database from 10 comprehensive stroke centers inside and outside the USA from January 2017 to January 2020 was reviewed. Patients were included if they had symptomatic intracranial stenosis ≥70% in the target vessel, failed best medical management, and underwent intracranial stenting with DES. The primary outcome was the occurrence of ischemic stroke, hemorrhage, or mortality within 72 hours of the procedure. Secondary outcomes included rates of symptomatic and angiographic recurrence within 6 months of the procedure. Results: There was a total of 129 patients, the median age was 65 [58-72] years, 40 (31%) were females. The intracranial stenotic lesions were located in anterior circulation in 74 (57.4%) of cases [24 (18.6%) supraclinoid ICA, 5 (3.9%) cavernous ICA, 17 (13.2%) petrous ICA, 5 (19.4%) MCA-M1, and 3 (2.3%) M2] and in posterior circulation in 55 (42.6%) of cases [36 (27.9) vertebral artery V4 segment, 18 (14%) basilar and 1 (0.7%) PCA]. Recurrent stroke was the qualifying event in 101 (78.3%) while transient ischemic attacks (TIA) were identified in 28 (21.7%) of cases. The median time from the qualifying event to stenting was 6 [2-24] days. Strokes were reported within 72 hours of the procedure; 2 (1.6%) ischemic, 2 (1.6%) hemorrhagic strokes and 2 (1.6%) patients suffered inpatient mortality. The median follow-up time was 6 [3-6.75] months. Among 99 patients who had clinical follow up 2 (2%) had TIA and 6 (6.1%) had strokes. Fifty-one patients had follow-up imaging of whom symptomatic ISR was reported in 8 (15.7%). Conclusion: Our study has shown that in appropriately selected patients with sICAD, endovascular treatment using DES is safe and effective. Prospective randomized clinical trials are warranted.

scholarly journals Morphine in the Setting of Acute Heart Failure: Do the Risks Outweigh the Benefits?

2020 ◽  
Vol 6 ◽  
Author(s):  
Oren Caspi ◽  
Doron Aronson
Keyword(s):  
Heart Failure ◽  
Adverse Event ◽  
Acute Heart Failure ◽  
Observational Studies ◽  
Retrospective Studies ◽  
Acute Pulmonary Oedema ◽  
Physiological Effects ◽  
Future Perspectives ◽  
Safety And Efficacy ◽  
Clinical Benefits

The use of opioids in acute pulmonary oedema is considered standard therapy by many physicians. The immediate relieving effect of morphine on the key symptomatic discomfort associated with acute heart failure, dyspnoea, facilitated the categorisation of morphine as a beneficial treatment in this setting. During the last decade, several retrospective studies raised concerns regarding the safety and efficacy of morphine in the setting of acute heart failure. In this article, the physiological effects of morphine on the cardiovascular and respiratory systems are summarised, as well as the potential clinical benefits and risks associated with morphine therapy. Finally, the reported clinical outcomes and adverse event profiles from recent observational studies are discussed, as well as future perspectives and potential alternatives to morphine in the setting of acute heart failure.

Dupilumab safety and efficacy in uncontrolled asthma: a systematic review and meta-analysis of randomized clinical trials

2018 ◽  
Vol 56 (10) ◽  
pp. 1110-1119 ◽  
Author(s):  
Yazan Zayed ◽  
Babikir Kheiri ◽  
Momen Banifadel ◽  
Michael Hicks ◽  
Ahmed Aburahma ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Uncontrolled Asthma ◽  
Safety And Efficacy

Safety Signal Detection in the Drug Development Process

2015 ◽  
pp. 64-89
Author(s):  
Ramin B. Arani ◽  
Antoni F.Z. Wisniewski
Keyword(s):  
Adverse Event ◽  
Drug Development ◽  
Signal Detection ◽  
Safety Information ◽  
Safety Signal ◽  
Drug Development Process ◽  
Safety And Efficacy ◽  
Strength Of Association ◽  
Efficacy Profile ◽  
Complicated Task

Drug development is a complex set of inter-linked processes in which the cumulative understanding of a drug's safety and efficacy profile is shaped during different learning phases. Often, drugs are approved based on limited safety information, for example in highly at risk or rare disease populations. Therefore, post approval, regulatory organizations have mandated proactive surveillance strategies that include the collection of reported adverse events experienced by exposed populations, some of whom may have been on treatment for extended periods of time. Analyzing these accumulating adverse event reports to understand their clinical significance, given the limitations imposed by the methods of data collection, is a complicated task. The aim of this chapter is to provide the readers with a general understanding of safety signal detection and assessment, followed by a description of statistical methods (both classical and Bayesian) typically utilized for quantifying the strength of association between a drug and an adverse event.

scholarly journals Multidose Pharmacokinetics of Ritonavir and Zidovudine in Human Immunodeficiency Virus-Infected Patients

1998 ◽  
Vol 42 (7) ◽  
pp. 1788-1793 ◽  
Author(s):  
Allen Cato ◽  
Jiang Qian ◽  
Ann Hsu ◽  
Benjamin Levy ◽  
John Leonard ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Adverse Event ◽  
Dosage Adjustment ◽  
Elimination Rate ◽  
Time Curve ◽  
Safety And Efficacy ◽  
Concentration Time ◽  
Immunodeficiency Virus ◽  
Asymptomatic Human Immunodeficiency Virus

ABSTRACT The effect of coadministration of ritonavir and zidovudine (ZDV) on the pharmacokinetics of these drugs was investigated in a three-period, multidose, crossover study. Eighteen asymptomatic, human immunodeficiency virus-positive men were assigned randomly to six different sequences of the following three regimens: ZDV (200 mg every 8 h [q8h]) alone for 4 days, ritonavir (300 mg q6h) alone for 4 days, and ZDV with ritonavir for 4 days. Ritonavir pharmacokinetics were unaffected by coadministration with ZDV. However, ZDV exposure was reduced by about 26% (P < 0.05) in the presence of ritonavir. The maximum concentration in (C max) of ZDV plasma decreased from 748 ± 375 (mean ± standard deviation) to 546 ± 296, and area under the concentration-time curve from 0 to 24 h (AUC0–24) decreased from 3,052 ± 1,007 to 2,261 ± 715 when coadministered with ritonavir. In contrast, the ZDV elimination rate constant was unaffected by ritonavir, suggesting that there was no change in ZDV systemic metabolism. Correspondingly, differences in ZDV-glucuronide C max and AUC were not statistically significantly different between regimens (P > 0.31). Also, there were no apparent differences in the formation of 3′-amino-3′-deoxythymidine or in the adverse event profiles between the regimens. The lack of change in ritonavir pharmacokinetics suggests that dosage adjustment of ritonavir is unnecessary when it is administered concurrently with ZDV. The clinical relevance of a 26% reduction in ZDV exposure when ZDV is administered with ritonavir is unknown. In addition to other multidrug regimens, the long-term safety and efficacy of coadministration of ritonavir and ZDV is being investigated.

scholarly journals Pharmacist-led intervention to improve medication use in older inpatients using the Drug Burden Index: a study protocol for a before/after intervention with a retrospective control group and multiple case analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e035656
Author(s):  
Marci Elizabeth Dearing ◽  
Susan Bowles ◽  
Jennifer Isenor ◽  
Olga Kits ◽  
Lisa Kouladjian O'Donnell ◽  
...  
Keyword(s):  
Nova Scotia ◽  
Statistical Tests ◽  
Inappropriate Medication ◽  
Medication Use ◽  
Adverse Outcomes ◽  
Control Group ◽  
Drug Burden Index ◽  
Older Inpatients ◽  
Registration Number ◽  
Multiple Case

IntroductionPolypharmacy and potentially inappropriate medication use is common in older adults and is associated with adverse outcomes such as falls and hospitalisations.Methods and analysisThis study is a pharmacist-led medication optimisation initiative using an electronic tool (the Drug Burden Index (DBI) Calculator) in four hospital sites in the Canadian province of Nova Scotia. The study aims to enrol 160 participants between the preintervention and intervention groups. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013 checklist) was used to develop the protocol for this prospective interventional implementation study. A preintervention retrospective control cohort and a multiple case study analysis will also be used to assess the effect of intervention implementation. Statistical analysis will involve change in DBI scores and assessment of clinical outcomes, such as rehospitalisation and mortality using appropriate statistical tests including t-test, χ2, analysis of variance and unadjusted and adjusted regression methods.Ethics and disseminationEthics approval has been granted by the Nova Scotia Health Authority Research Ethics Board. The findings of this study will be published in peer-reviewed journals and presented at local, national and international conferences.Trial registration numberNCT03698487.

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